Surgical access port

ABSTRACT

A device for retracting edges of an incision in a surface to form an opening including: a flexible, tubular skirt having an upper end, a lower end, and a channel therebetween; a ring connected to the lower end of the skirt for maintaining the lower end in an open configuration and defining an exit opening to the channel; and an inflatable collar connected to the skirt and surrounding the upper end. The ring is designed to fit through the incision and remain under the surface when it is oriented parallel to surface. The collar, when inflated, maintains the upper end in an open configuration and defines an entry opening to the channel. During use, the ring is inserted through the incision and the collar is inflated while remaining outside of the incision, thereby drawing the skirt against he edges of the incision and retracting the edges of the incision to form the opening. The retracting device can be included in a surgical access port, which further includes a flexible sleeve connected to at least one of the inflatable collar and the skirt, extending the channel from the exit opening of the skirt to an open end of the flexible sleeve distal to the skirt. The device can include a light source in the vicinity of the exit opening.

BACKGROUND OF THE INVENTION

[0001] This invention relates to the field of surgical devices. Moreparticularly, the invention relates to a surgical access port, whichprovides a gas-tight seal for a hand or instrument to be insertedthrough the opening into a patient's body cavity.

[0002] Abdominal surgery typically involves an incision in the abdominalwall large enough to accommodate a surgeon's hands, multipleinstruments, and illumination of the body cavity. While large incisionssimplify access to the body cavity during a surgery, they also increasetrauma, require extended recovery time, and can result in unsightlyscars. In response to these drawbacks, minimally invasive surgicalmethods have been developed.

[0003] In minimally invasive abdominal surgery, several smaller incisionare made into the abdominal wall. One of the openings is use to inflatethe abdominal cavity with gas, which lifts the abdominal wall away fromunderlying organs and provides space to perform the desired surgery.This process is referred to as insufflation of the body cavity.Additional openings can be used to accommodate instruments forilluminating and viewing the cavity, as well as instruments involved inactually performing the surgery, e.g., instruments to manipulate, cut,or resect organs and tissue. While minimally invasive surgical methodsovercome certain drawbacks of traditional methods, there are stillvarious disadvantages. In particular, there is limited tactile feedbackfrom the manipulated tissue to the surgeon hands. Also, tissue that isto be removed from the body cavity must be removed in pieces that aresmall enough to fit through one of the incisions.

[0004] Recently, new surgical methods have been developed that combinethe advantages of the traditional and minimally invasive methods. Inthese new methods, small incisions are still used to inflate,illuminate, and view the body cavity, but in addition, an intermediateincision is made into the abdominal wall to accommodate the surgeon'shand. The intermediate incision must be properly retracted to provide asuitable-sized opening, and the perimeter of the opening is typicallyprotected with a surgical drape to prevent bacterial infection. Asealing mechanism is also required to prevent the loss of insufflationgases while the surgeon's hand is either inserted into or removed fromthe body cavity though the retracted incision.

SUMMARY OF THE INVENTION

[0005] The invention features a surgical access port that allows asurgeon's hand or instrument to access a patient's body cavity through asealed opening. The access port includes two parts, a wound retractorand a sealing sleeve. The wound retractor is designed to retract theedges of an incision made into a body cavity into an opening, and toseal around the edges of the opening, thereby forming a gas-tightconnection between the body cavity and the interior of the access port.The sealing sleeve connects to the wound retractor external to the bodycavity and provides a path for a surgeon to insert his hand through theopening formed by the wound retractor. The sealing sleeve seals around asurgeon's arm or a surgeon's glove, when the surgeon's hand is insertedinto the body cavity, and seals the opening when the surgeon's hand isremoved from the access port. Thus, the port provides hand access to thebody cavity, and prevents gases in the body cavity, such as insufflationgases, from escaping into the surroundings.

[0006] In general, in one aspect, the invention features a device forretracting edges of an incision in a surface to form an opening. Thedevice includes: a flexible, tubular skirt having an upper end, a lowerend, and a channel therebetween; a ring connected to the lower end ofthe skirt for maintaining the lower end in an open configuration anddefining an exit opening to the channel; and an inflatable collarconnected to the skirt and surrounding in the upper end. The ring isdesigned to fit through the incision and remain under the surface whenit is oriented parallel to the surface. The collar, when inflated,maintains the upper end in an open configuration and defines an entryopening to the channel. During use, the ring is inserted through theincision and the collar is inflated while remaining outside of theincision, thereby drawing the skirt against the edges of the incisionand retracting the edges of the incision to form the opening.

[0007] The retracting device can include the following features. Thecollar when fully inflated has an inner aperture having a diametergreater than the length of the incision. The device can also include alight source, such as an optic fiber or fiber optic cable, connected tothe lower end of the skirt. The skirt can include a hem-shaped pocketthat encloses the ring. The ring can be formed by filling a pocket withat least one of a gas and a liquid. The ring can have a substantiallyelliptical shape. The device can also include a second ring adjacent toan outer perimeter of the inflatable collar for reinforcing the entryopening, as well as a detachable cap, adapted to be received by thesecond ring, for sealing the entry opening. Furthermore, the device caninclude an inflatable cuff connected to an inner wall of the skirt andsurrounding the entry opening for sealing around a surgeon's arminserted into the channel, as well as a detachable plug, adapted to bereceived by the inflatable cuff, for covering the entry opening.

[0008] The retracting device can be included in a surgical access port,which further includes a flexible sleeve connected to at least one ofthe inflatable collar and the skirt, extending the channel from the exitopening of the skirt to an open end of the flexible sleeve distal to theskirt. In some embodiments, the flexible sleeve can be removed andreattached to the device, or it can be permanently affixed. The accessport can include a light source connected to the skirt in the vicinityof the exit opening, and the flexible sleeve can include an iris valve.

[0009] In one embodiment of the access port, the flexible is sleeveincludes an inner sleeve and an outer sleeve forming a chambertherebetween, and an inlet port for inflating the chamber, wherebyinflating the chamber compresses together a central portion of the innersleeve, thereby sealing the channel. A pair of drawstrings can beattached to opposite sides of the central portion of the inner sleeveand pull the sides in opposite directions toward the outer sleeve,thereby collapsing the central portion of the inner sleeve into twoflattened portions contacting each other to form a seal. Furthermore,the central portion of the inner sleeve can include two sealed regionsopposite one another in which immediately adjacent portions of the innersleeve are welded together, thereby dividing the central portion intotwo substantially flattened portions extending along the length of thechannel adjacent to one another.

[0010] In another embodiment, the access port includes a flap valve thatconnects to the open end of the flexible sleeve and extends into thechannel. The flap valve seals the channel when there is a positivepressure differential between the channel and the surroundings. A pairof drawstrings can be attached to opposite ends of the flap valve andpull the ends in opposite directions to enhance the sealing ability ofthe flap valve.

[0011] In a further embodiment, the access port includes an inflatablecuff attached to an inner surface of the sleeve for sealing around asurgeon's arm. The inflatable cuff can be surrounded by a backing of asubstantially non-expandable material. Furthermore, a second ring can beconnected to the sleeve and surround the open end of the sleeve. To sealthe open end, a detachable cap adapted to be received by the second ringcan be used.

[0012] In another embodiment, the access port can include a sealingcollar attached to the sleeve and surrounding the open end, and a glovehaving a flange at the open end of the glove. The sealing collar canhave a groove along its inner perimeter that mates with or engages theflange and seals the channel when inserted into the groove.

[0013] In a related embodiment, the access port includes a sealingcollar attached to the sleeve and surrounding the open end, and a glovehaving an enlarged cuff. The sealing collar including an inwardlyexpanding inflatable bladder that mates with the enlarged cuff and sealsthe opening when the glove is inserted into the sleeve.

[0014] In another related embodiment, the access port includes a sealingcollar attached to the sleeve and surrounding the open end, a bracelethaving a fixed diameter, and a surgical glove. The sealing collar has agroove along its inner perimeter that mates with the bracelet. Duringuse, the bracelet is worn by a surgeon underneath the surgical glove andis mated to the sealing collar so that a portion of the glove is heldwithin the groove, by the bracelet, thereby sealing the channel.

[0015] In another aspect, the invention features a surgical access port,for use with a surgical glove, including a device for retracting theedges of a surgical incision to form an opening into a patient's bodycavity, a sealing sleeve attached to the device external to the bodycavity, and a semi-rigid bracelet having a fixed diameter. The sealingsleeve includes a flexible sleeve providing a channel from its open enddistal to the retracting device through to the opening, and a sealingcollar attached to the sleeve and surrounding the open end that mateswith the bracelet. During use, the bracelet is worn by a surgeonunderneath the surgical glove and is mated to the sealing collar,thereby fastening a portion of the clove to the sealing collar andsealing the channel. In some embodiments, the access port furtherincludes the surgical glove.

[0016] The invention also features a method of using the new accessports. The steps include: placing the bracelet around an arm of thesurgeon; placing the glove over a hand of the surgeon so that the gloveextends over the bracelet; inserting the gloved hand into the accessport; and attaching the portion of the inserted glove to the access portby mating the bracelet with the sealing collar of the access port.

[0017] In further aspects, the invention features a surgical access portincluding a device for retracting the edges of a surgical incision toform an opening into a patient's body cavity and a sealing sleeveattached to the device external to the body cavity. The sealing sleeveincludes a flexible sleeve providing a channel from its open end distalto the retracting device through to the opening and a mechanism forsealing the channel. The mechanism includes drawstrings.

[0018] In one embodiment, the sealing sleeve further includes an outersleeve surrounding the flexible sleeve and forming a chambertherebetween, and an inlet port for inflating the chamber. Inflating thechamber compresses together a central portion or the flexible sleeve,thereby sealing the channel. The drawstrings attach to opposite sides ofthe central portion of the flexible sleeve, pulling the sides inopposite directions toward the outer sleeve, thereby imparting apreferred flattened geometry to the central portion of the inner sleeveand enhancing the seal.

[0019] In another embodiment, the mechanism further includes a flapvalve that connects to the open end of the flexible sleeve and extendsinto the channel. The flap valve seals the channel when there is apositive pressure differential between the channel and the surroundings.The drawstrings attach to opposite ends of the flap valve, pulling theends in opposite directions, enhancing the sealing ability of the flapvalve.

[0020] Unless otherwise defined, all technical and scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which this invention belongs. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, suitable methods andmaterials are described below. All publications, patent applications,patents, and other references mentioned herein are incorporated byreference in their entirety. In case of conflict, the presentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

[0021] The invention has the following advantages.

[0022] Since the edges of the incision are retracted by simply inflatingthe collars, the wound retractor is easy to use. Furthermore, the woundretractor provides a seal around the perimeter of a retracted wound,from the inner abdominal wall to the surface of the skin. The sealprevents infection and provides a gas-tight connection between the bodycavity and the remainder of the access port.

[0023] In the sealing sleeve portion of the access port, the flap valveand the inner sleeve, which is compressed by the inflatable chamber,provide a gas-tight seal around a surgeon's arm when the surgeon's handis inserted into a patient's body cavity. This seal preventsinsufflation gases from escaping. The effectiveness of this seal isimproved by the drawstrings.

[0024] A light source connected to the base of the wound retractor canbe used to illuminate the body cavity, making additional incisions forendoscopic illuminating means unnecessary.

[0025] Other features and advantages of the invention will be apparentfrom the following detailed description, and from the claims.

BRIEF DESCRIPTION OF THE DRAWING

[0026]FIG. 1 is a cross-sectional view of a surgical access port.

[0027]FIGS. 2A to 2E illustrate the steps in using the wound retractorportion of the access port of FIG. 1.

[0028]FIG. 3 is a cross-sectional view of a another embodiment thesurgical access port of FIG. 1.

[0029]FIG. 4 is a cross-sectional view of a another embodiment of asurgical access port.

[0030]FIG. 5 is a schematic of a modular surgical access port.

[0031]FIGS. 6A and 6B are schematic views of an iris valve in open andclosed configurations, respectively.

[0032]FIGS. 7A and 7B are a cross-sectional views of another embodimentof a surgical access port.

[0033]FIG. 8 is a cross-sectional view of an embodiment of a woundretractor.

[0034]FIG. 9 is a cross-sectional view of another embodiment of a woundretractor.

[0035]FIG. 10 is a perspective view of an embodiment of the access portemploying a glove.

[0036]FIG. 11 is a perspective view of another embodiment of the accessport employing a glove.

[0037]FIG. 12 is a perspective view of a further embodiment of theaccess port employing a glove.

[0038]FIG. 13 is a schematic of a wound retractor having a light sourcefor illuminating the body cavity.

DETAILED DESCRIPTION

[0039] The surgical access port is best described as having two parts, awound retractor and a sealing sleeve.

[0040] The wound retractor includes a flexible tubular skirt having afirst end reinforced with a stiff ring so that the first end ismaintained in an open orientation, and a second end surrounded by one ormore inflatable collars. The reinforced first end is inserted into thebody cavity through an incision, providing a channel through the skirtfrom the outside to the inside of the body cavity. During use, thecollars are inflated, thereby drawing out skirt within the incision andpulling the reinforced first end of the skirt tight against the innerwall of the patient's skin. As a result, the edges of the incision areretracted into an opening and the skirt seals around the perimeter ofthe opening along the inner abdominal wall to the outer surface of theskin.

[0041] A sealing sleeve is attached to the wound retractor portion abovethe inflatable collars. The sealing sleeve has an entry opening distalto the collars and extends the channel provided by the skirt. Within thesealing sleeve, a gas-tight seal is provided for conforming to the shapeof an object (e.g., a hand or instrument) inserted through the channelinto the body cavity.

[0042] Alternatively, the sealing sleeve can include means for attachinga surgeons glove to the entry opening of the sleeved. In these cases,the exterior of the glove seals the channel while a surgeon's hand canbe inserted into the interior of the glove and access the body cavity.

Surgical Access Ports

[0043] As shown in FIG. 1, surgical access port 62 is a sleeve-likedevice having an entry opening 12 and an exit opening 18. During use, asurgeon inserts a hand into the entry opening 12 and accesses apatient's body cavity through exit opening 18, after the access port isinserted into the body cavity through an incision, and prevents gasesused to insufflate the body cavity from escaping through the incision. Aflexible skirt 66 surrounds exit opening 18 and has a hem-like pocket 63at its end proximal to exit opening 18. Pocket 63 encloses a ring 64 sothat the skirt and exit opening 18 are maintained in an open,substantially circular or elliptical orientation. Skirt 66 extendsupward from exit opening 18 towards one or more inflatable collars 68and 69 that surround skirt 66. The upper end of skirt 66 is connected tothe upper-most collar 69, from the inner circumference of collar 69 tothe top of collar 69. Each of the inflatable collars 68 and 69respectively enclose an annular region. The annular regions may or maynot be in fluid contact with one another, but they are isolated from therest of the sleeve, body cavity, and surrounding. The collars 63 and 69are inflated through one or more inlet ports 11. When collars 68 and 69are in fluid communication with one another, only a single inlet port 11is required.

[0044] An outer sleeve 10 is attached to the upper end of skirt 66 andextends upward towards entry opening 12. Outer sleeve 10 encloses anupper chamber 16, which is in fluid contact with gases from the bodycavity when exit opening 18 is inserted through an incision into thebody cavity. Outer sleeve 10 is inverted at the entry opening 12 forminga flap valve 14, which seals upper chamber 16 from the surroundingsexternal to entry opening 12.

[0045] The lower portion of access port 62, which includes ring 64,skirt 66, and inflatable collars 68 and 69, form the wound retractor.During use, an incision 50, e.g., in the shape of a slit (FIG. 2A) isfirst made in the patient's abdominal wall 52. Ring 64 and the attachedportion of skirt 66 are then inserted into the body cavity throughincision 50 with collars 68 and. 69 being uninflated and remainingexternal to incision 50 (FIG. 2B). If ring 64 is circular and has adiameter less than the length of incision 50, it is insertedperpendicular to abdominal wall 52. Alternatively, if ring 64 iscircular and its diameter is greater than the length of incision 50,ring 64 must be flexible enough to fit through incision 50 in a deformedstate. Most preferably, ring 64 is rigid and has an elliptical shapewith a maximum diameter longer than the length of incision 50 and aminimum diameter shorter than the length of incision 50. In this case,rigid ring 64 is inserted into the body cavity by orienting its minimumdiameter parallel to incision 50.

[0046] Once ring 64 is within the body cavity, it is oriented so that itis parallel to the abdominal wall 52 (FIGS. 2C and 2D). FIGS. 2C and 2Dare cross-section views along the length and width, respectively, ofincision 50, with collars 68 and 69 remaining uninflated. In thisconfiguration, the diameter and stiffness of ring 64 are sufficient toprevent it from being pulled back through incision 50. The collars 68and 69, which have diameters equal to or greater than the length ofincision 50, are then inflated though inlet port 11. Collars 68 and 69initially rest above abdominal wall 52 around incision 50. As collars 68and 69 are inflated, they expand upward and their inner circumferencesexpand radially outwardly (FIG. 2E). Since the upper end of skirt 66 isconnected to the inner circumference of the upper-most collar 69, skirt66 is also drawn upwards and radially outward, thereby drawing ring 64tightly against the inner surface of abdominal wall 52. As a result, theintermediate portion of skirt 66 is drawn tightly against the edges ofincision 50, retracting the adjacent tissue and producing an openinginto the body cavity and a gas-tight seal between the body cavity andthe remainder of access port 62. FIG. 2E illustrate a cross-sectionalview of incision 50 with collars 68 and 69 being inflated.

[0047] Once the wound retractor of access port 62 has provided agas-tight seal around incision 50, the body cavity is inflated with gas.The gas also expands into upper chamber 16, inflating the upper portionof access port 62. The pressure within upper chamber 16 seals flap valve14, which prevents gas from escaping through entry opening 12. Theportion of flap valve 14 distal to entry opening 12 has a preferredflattened orientation formed by heat sealing side portions 15 a and 15 bof flap valve 14 (FIG. 3). As the flap valve extends upward towardsentry opening 12, it opens into an approximately circular geometry.During use, the surgeon inserts his hand into upper chamber 15 throughentry opening 12 and flap valve 14. Insertion of the surgeon's handmomentarily breaks the seal between side portions 15 a and 15 b of flapvalve 14, but thereafter the pressure within upper chamber seals flapvalve 14 around the surgeon's arm. The loss of insufflation gases isthereby minimized during insertion and subsequent removal of thesurgeon's hand. Since these gas losses are small, they can becompensated for easily by known pumping means used for inflating andregulating pressure in the body cavity.

[0048] To prevent flap valve 14 from everting as a result of positivepressure in the upper chamber, the portion of the access port extendingfrom the upper portion of outer sleeve 10 toward flap valve 14 alongentry opening 12 can be reinforced with additional material to stiffenthe access port in this region, and to maintain the preferredorientation, i.e., to prevent eversion.

[0049] In addition or alternatively, heat-sealed side portions 15 a and15 b can be provided with eyelet openings 20 a and 20 b through whichdrawstring 22 a and 22 b are attached (FIG. 3). Drawstrings 22 a and 22b extend in opposite directions such that tension placed upon them pullsthe two walls of flap valve 14 into close approximation. The drawstringspass through the walls of outer sleeve 10 via drawstring ports 24 a and24 b. Drawstring ports 24 a and 24 b form a friction fit arounddrawstrings 22 a and 22 b sealing upper chamber 16 from the surroundingsand fixing the respective lengths of the drawstrings in upper chamber16. Tension on drawstrings 22 a and 22 b can be increased by pulling onthe drawstrings from the outside of outer sleeve 10, even as access port62 is in use. In certain embodiments, drawstring ports 24 a and 24 b canfurther include one-way releasable locking mechanisms so that tension onthe drawstrings can be increased and decreased from the outside of outersleeve 10. The drawstrings prevent the inversion of flap valve 14 whenupper chamber 16 is inflated and enhance the effectiveness of the flapvalve seal, with and without insertion of a surgeon's hand.

[0050] In an alternative embodiment, drawstrings 22 a and 22 b are madeof an elastic material and fixedly attached to the inner wall of outersleeve 10. In this embodiment, the drawstrings do not extend outwardthrough outer sleeve 10 and so the tension on them is not adjustable.Instead, the drawstrings are cut to a specific length to provide apreset tension on the flap valve opening when the upper chamber is fullyexpanded.

[0051]FIG. 4 shows another embodiment of hand access port 62, whichdiffers from the embodiments described previously in the following way.Flap valve 14 is replaced with a flexible and expandable inner sleeve 30that extends from entry opening 12 and attaches to skirt 66 near theuppermost collar. As a result, upper chamber 32 is completely isolatedfrom the body cavity and the surroundings. Instead of being inflated byinsufflation gases from the body cavity, upper chamber 32 is inflatedseparately through inlet port 34.

[0052] The interior of inner sleeve 30 provides a channel from entryopening 12 to the wound retractor. When upper chamber 32 is inflated,the positive pressure in upper chamber 32 collapses together the wallsof expandable inner sleeve 30, thereby sealing the channel, oralternatively, sealing inner sleeve 30 around the arm of a surgeon.

[0053] Inner sleeve 30 includes a central portion having a flattenedorientation formed by heat sealing side portions 38 a and 38 b. Hence,the circumference of inner sleeve 30 begins substantially circular nearentry opening 12, becomes elongate in the vicinity of side portions 38 aand 33 b, and becomes substantially circular again in the vicinity ofcollars 68 and 69. As described previously, the access port can alsoinclude eyelet openings 40 a and 40 b in side portions 38 a and 38 b,through which drawstrings 42 a and 42 b are attached, respectively. Thedrawstrings extend outwardly through drawstring ports 44 a and 44 b.When upper chamber 32 is inflated to a pressure greater than thepressure in the body cavity and the surroundings, the positive pressurecollapses together the walls of inner sleeve 30 between side portions 38a and 38 b, sealing the body cavity from entry opening 12. As a resultof drawstrings 42 a and 42 b, this seal is enhanced.

[0054] During use of this embodiment, the wound retractor portion ofaccess port 62 is implemented as described previously (and shown inFIGS. 2A-2E). Upper chamber 32 is then inflated, sealing the body cavityfrom the surroundings. Following this step, the body cavity isinsufflated. If the pressure in the body cavity is greater than pressurein upper chamber 32, the seal will leak insufflation gas to thesurroundings, otherwise the seal will be maintained. In this way, theisolated upper chamber 32 insures that the insufflation pressure in thebody cavity will remain below the pressure in the upper chamber. As thesurgeon inserts his hand through access port 62 and into the bodycavity, the positive pressure from upper chamber 32 will force innersleeve 30 to conform to the shape of the surgeon's arm, therebymaintaining the seal. As mentioned before, any loss of insufflation gasduring the insertion and removal of the surgeon's hand can becompensated for by the insufflation pump.

[0055] Access port 62 may further include a one-way relief valve 46,such as a duck-billed relief valve, between upper chamber 32 and aregion within inner sleeve 30 proximal to inflatable collars 68 and 69.A duck-billed relief valve is a one-way valve that opens when there is asufficient pressure differential between opposite sides of the valve. Inthis embodiment, relief valve 46 would begin to leak if the pressure inupper chamber 32 became too large. For example, when the surgeon's armis within inner sleeve 30, the volume of upper chamber 32 becomescompressed, thereby increasing the pressure within upper chamber 32 andagainst the surgeon's arm. This may be uncomfortable for the surgeon.Advantageously, relief valve 46 would optimize the effectiveness of theseal around the surgeon's arm and the comfort of the surgeon byreleasing gas from upper chamber 32 to the body cavity. The insufflationpump used to inflate upper chamber 32 could compensate for any loss ofgas from upper chamber 32 that may be required to maintain an effectiveseal once the surgeon removes his hand.

[0056] Relief valve 46 also allows the body cavity to be insufflatedwith the same pump used to inflate upper chamber 32. Once the pressurein Upper chamber 32 reaches a preset value, gas will leak through reliefvalve 46 insufflating the body cavity. The seal between the entryopening and the body cavity will be maintained since the pressure inupper chamber will remain larger than the pressure in the body cavity.In a further embodiment, the access port includes a second one-wayrelief valve extending from inflatable collars 63 and 69 to the upperchamber. Thus, a single pumping means could be used to first inflatecollars 68 and 69, then inflate upper chamber 32, and finally inflatethe body cavity. The relief valves would require that the pressure incollars 68 and 69 is greater than the pressure in upper chamber 32,which is greaser than the pressure in the body cavity.

[0057] A relief valve may also be positioned between upper chamber 32and a region of inner sleeve 30 proximal to entry opening 12. In thiscase gas will leak for the upper chamber into the surroundings.

Access Port Variations

[0058] In another embodiment, the access port described above having aninner and outer sleeve can also include a second pair of drawstrings forimparting a second region of the inner sleeve with a preferred flattenedgeometry. Thus, when the seal formed bay the first flattened region isbroken during the insertion or removal of a surgeon's hand, pressurefrom the inflated upper chamber provides a second seal at the secondflattened region, or vice-versa.

[0059] Alternatively, for any of the embodiments described previously, aflap valve can be connected to the skirt and extend into the woundretractor, thereby providing a second seal on the surgeon's arm. Thus,when the surgeon's hand breaks either seal, the remaining seal preventsthe escape of insufflation gases.

[0060] In a further embodiment, the surgical access port can be modularas shown in FIG. 5, comprising a wound retractor 200 (as describedabove) and a sealing sleeve 202. Depending on the particular embodiment,the sealing sleeve could, for example, include an outer sleeve having aflap valve seal within an entry opening (e.g., the embodiment shown inFIG. 1) or an inflatable chamber formed between an inner and outersleeve (e.g., the embodiment shown in FIG. 4). For surgical proceduresthat do not require insufflation of the body cavity, the Wound retractorcan be used on its own for retracting an incision to make an openinginto the body cavity. When insufflation of the body cavity is necessary,the sealing sleeve is attached to the wound retractor using a reusablegas-tight attachment means 204, such as a zip-lock seal. Alternatively,for example, the attachment means can include a compression or threadedfit between a pair of semi-rigid collars attached to the sealing sleeveand wound retractor, respectively. Otherwise, the surgical access portis structured and functions similarly to the embodiments describedabove.

[0061] In other embodiments, the wound retractors described herein canbe used with other types of sealing sleeves. In particular, rather thansealing means based on inflation, mechanical sealing means well known inthe art can be provided. For example, as shown in FIGS. 6A and 6B, thesealing sleeve can include an iris valve 76 attached to the upper end ofthe skirt above the inflatable collars. The iris valve is formed fromtwo stiff rings 70 and 72 attached to opposite ends of a tubular piece74 of elastic material (FIG. 6A). In this configuration, iris valve 76is open. To seal the opening, or alternatively, to seal around asurgeon's arm inserted through the opening, the upper ring 72 is rotatedrelative to the lower ring 70, as a result tubular piece of elasticmaterial 74 becomes twisted and the opening through the tubular piececontracts (FIG. 6B). To lock the relative positions of the upper andlower rings, the rings are attached to one another using a claspingmechanism 73 and 80, e.g., a latch.

[0062] Alternatively, for example, the lower ring can be provided withupright pegs evenly spaced around its circumference. The upright pegsfit into corresponding openings in the upper ring, so that when theupper ring is placed on the lower ring the rotational position of therings relative to one another is fixed.

[0063] Another embodiment of a sealing sleeve 101 is shown in FIGS. 7Aand 7B. The top end 108 of sleeve 10 is maintained in an openconfiguration by its connection to a rigid ring 110. Just below rigidring 110, the inner wall of sleeve 100 is connected to an inflatablecuff 112, which is made out of an expanding, elastomeric material (e.g.,rubber). Surrounding inflatable cuff 112 on the outside of sleeve 10 isa stiff backing 100 of a close-fitting non-expanding material (e.g., anylon weave). Since backing 100 is non-expanding, cuff 112 will expandinward when inflated, thereby sealing around a surgeon's arm when thesurgeon's hand is inserted through the channel formed by wound retractor106. Furthermore, since there is a region of flexible material betweencuff 112 and wound retractor 106, the surgeon can easily alter the angleof his arm and the penetration depth of his hand, without jeopardizingthe seal formed by cuff 112. When the surgeon's hand is removed from theaccess port, cuff 112 can be inflated further to completely seal thechannel.

[0064] Alternatively, to seal the channel when the surgeon's hand isremoved, rigid ring 110 can receive a snap-on cap 114 (FIG. 7B), whichcovers the opening at the top end 108 of sleeve 100. The cap is made ofa semi-flexible material, which includes, for example, hard rubber,polyvinyl chloride (PVC), and foam. Cap 114 includes a groove 117, abovea lower inner lip 116, that mates with rigid ring 110. The mechanicalpressure created by a slight undersizing of the diameter of groove 117above inner lip 116 relative to the diameter of rigid ring 110 forms atight seal. Cap 114 can also include instrument ports 118 and 120, whichprovide gas-tight sealable openings into the body cavity for surgicalinstruments (e.g., trocars, cannulas, and endoscopes).

[0065] In another embodiment, shown in FIG. 8, the wound retractordescribed previously can further include a rigid ring 210 surroundingthe outer perimeter of inflatable collars 68 and 69. For example, skirt66 can extend over, and connect to, the outer perimeter of inflatablecollars 68 and 69, enclosing rigid ring 210 between these collars.Alternatively, for example, one of the inflatable collars can includeadditional material for enclosing rigid ring 210 around the outerperimeter of that collar. Rigid ring 210 will help prevent collars 68and 69 from deforming in response to forces from the retracted openingwhen inflated, and will provide structure to the top part of a woundretractor 212 when collars 68 and 69 are uninflated. Furthermore, rigidring 210 allows snap-on cap 114 to directly cover the channel providedby wound retractor 212. Cap 114 is mounted onto ring 210 by acompression fit. The diameter of rigid ring 210 is slightly larger thanthe diameter of groove 117 above lower lip 116, thereby forming a tightseal.

[0066] As shown in FIG. 9, wound retractor 224 can further include aninflatable cuff 220 attached directly to skirt 66 of the wound retractoradjacent to the inner perimeter of inflatable collars 68 and 69. In thiscase, wound retractor 224 includes a sealing means for the channel intothe body cavity (i.e., cuff 220) and a sealing sleeve is unnecessary.Cuff 220 is made of an expandable, elastomeric material and will expandinward when inflated, sealing around a surgeons arm that is insertedthrough the channel formed by wound retractor 224. When the surgeon'sarm is removed, cliff 220 can either be inflated to completely seal thechannel, or alternatively, cuff 220 can receive a sealing plug 230.After plug 230 is inserted into wound retractor 224, inflated cuff 220,when inflated, fits securely within recessed groove 232, thereby sealingthe channel. As with cap 114, sealing plug 230 can include one or moresealable instrument ports 234 for inserting instruments into the bodycavity through wound retractor 224.

Access Port Variations Using a Glove

[0067] In another series of embodiments shown in FIGS. 10-12, a seal ismade between the cuff of a clove worn by the surgeon and the opening ofthe sealing sleeve. A wound retractor 300 of an access port 302 providesan opening through an abdominal wall 304 into a body cavity 306. Aflexible tubular sleeve 310 is attached to wound retractor 300 externalto body cavity 306, extending the channel formed by wound retractor 300to an entry opening 312 of sleeve 310. A sealing collar 314 is connectedto sleeve 310 surrounding entry opening 312. Sealing collar 314 is formating to an enlarged cuff 317 of a glove 316 worn by a surgeon, therebysealing the channel from the surroundings.

[0068] Sleeve 310 can be provided with a means for closing the channelalong an intermediate portion 318 of sleeve 310 to seal the opening tobody cavity 306. For example, along a circumference 322 of intermediateportion 318, sleeve 310 can attach to a drawstring 320, which can bedrawn up external to sleeve 310 (FIG. 10). When drawstring 320 is drawnup, circumference 322 contracts until the channel into body cavity 306is completely covered by sleeve 310. In another embodiment, shown inFIG. 11, intermediate portion 318 can be closed by a “bear-trap” clamp330 comprising two hinged arcuate bands 332 and 334 connected to thebase of sleeve 310. When bands 332 and 334 extend away from one another,they surround the base of sleeve 310 and the channel remains open. Asbands 332 and 334 are brought together above wound retractor 300, theyforce together opposite inner surfaces of sleeve 310, thereby closingthe channel and sealing the opening to body cavity 306.

[0069] In a further embodiment, shown in FIG. 12, inner surfaces ofintermediate portion 318 of sleeve 310 include a zip-lock seal 340 forsealing the opening to body cavity 306. In other embodiments, a separatemechanical clamp can be used to hold inner surfaces or intermediateportion 318 together, thereby closing the channel.

[0070] During use, the closing means is used to seal the opening intobody cavity 300 formed by wound retractor 300. Body cavity 306 is theninsufflated, with the closing means preventing the escape ofinsufflation gases into the surroundings. Cuff 317 of surgeon's glove316 is then mated with sealing collar 314 and the closing means isreleased so that the surgeon's gloved hand can access body cavity 306.The open end of sleeve 310 is sealed to enlarged cuff 317, preventingthe escape of insufflation gases even though the closing meanssurrounding intermediate portion 318 is not in use. The length offlexible sleeve 310 provides the surgeon's arm with a sufficientmovement range. When the surgeon brings his gloved hand aboveintermediate portion 318, the closing means can be reset, therebyresealing the opening to body cavity 306. Thereafter, enlarged cuff 317is detached from sealing collar 314 and the surgeon's gloved hand isremoved from access port 302.

[0071] In one embodiment, enlarged cuff 317 includes aradially-outwardly extending flange 350 that mates with an inner groove352 within sealing collar 314. Flange 350 is made of a semi-rigidmaterial (e.g., plastic or rubber) that is sufficiently deformable forflange 350 to be inserted into sealing collar 314 and mate with groove352 (FIG. 10).

[0072] In the above embodiment, glove 316 can be a standard surgicalglove and flange 350 can be formed by placing a bracelet over thesurgeon's gloved hand and mounting the bracelet to the wrist portion ofthe glove using an adhesive material. In order to seal the channel, thebracelet is designed to mate with groove 352.

[0073] Alternatively, a bracelet 360 can be worn underneath glove 316(FIGS. 11-12). Again, glove 316 is a standard surgical clove, which istypically made of a flexible and semi-elastic material (e.g., latex,natural rubber, or polymeric materials). In this case, the surgeonplaces a bracelet 360 around his wrist and then pulls glove 316 over hishand and the bracelet. Glove 316 conforms to the shape of bracelet 360,thereby forming enlarged cuff 317, which completely surrounds the wristof the surgeon and can mate with sealing collar 314.

[0074] In these embodiments, bracelet 360 is made of a substantiallyrigid or semi-rigid material (e.g., an o-ring made of hard rubber) andhas a fixed diameter. Sealing collar 314 can comprise an inflatablebladder 364 for expanding against and mating with enlarged cuff 317(FIG. 11). Sealing collar 314 can also be made of a semi-compressiblematerial (e.g., foam or a gel-filled bladder), which provides aninterference fit with enlarged cuff 317. Alternatively, bracelet 360 canhave a cross-sectional shape designed to fit with an inner groove 370 ofsealing collar 314 (FIG. 12). Glove material pressed between fittedcollar 314 and bracelet 360 functions as a gasket, enhancing theeffectiveness of the seal.

[0075] In any of the embodiments using the bracelet and glove, the sealis maintained without constricting the surgeons arm, which can be asource of discomfort. The surgeon's arm is not constricted becausebracelet 360 has a fixed diameter and need only fit loosely around thesurgeon's arm. However, by mating with sealing collar 314, bracelet 360securely attaches glove 316 to entry opening 312 of sleeve 300, sealingthe opening to the body cavity, and allowing access to the body cavityvia glove 316.

[0076] Preventing the constriction of a surgeon's arm can be furtherachieved by an embodiment in which the cross-sectional diameter ofbracelet 360 along the length of the surgeons arm is slightly largerthan the corresponding dimension of groove 370. Hence, an interferencefit between the mating components is provided along a direction parallelto the surgeon's arm, and bracelet 360 is not compressed along adirection that will constrict a surgeon's arm.

[0077] In some embodiments, it is desirable for the diameter of bracelet360, and the glove itself, to be large enough that the surgeon canremove his hand from glove 316 without detaching glove 316 from sleeve310. In this case, access port 300, glove 316 and bracelet 360 combineto form a detachable glove box, in which, during use, the surgeon caninsert and remove his hand from the body cavity at will (via glove 316)with no loss of insufflation gas, and when the procedure is completed,glove 316 can be detached from access port 300.

[0078] It is worth pointing out, however, that the diameter of bracelet360 should not be too large to prevent a surgeon's range of movement. Inparticular, the diameter of enlarged cuff 317 formed by bracelet 360should be smaller than the diameter of the retracted incision. As aresult, the surgeon can completely insert his gloved hand and arm,including enlarged cuff 317, through the retracted opening into the bodycavity. Alternatively, the clove and cuff can be designed such that theglove extends up to, for example, a surgeon's elbow, and the cuff fitsaround the surgeon's upper forearm or elbow to provide the surgeon asufficient reach inside the body cavity.

[0079] In other embodiments, a separate mechanical or elastic clamp canbe used to attach glove 316 to the entry opening 312 of sleeve 310.Furthermore, in any of the above embodiments, additional mechanical orelastic, clamping or tightening means (e.g., elastic bands, drawstrings,or incremental tightening rings) can be used to enhance the sealprovided by the connection of enlarged cuff 317 to sealing collar 314.

Inclusion of a Light Source

[0080] In further embodiments, any of the embodiments describedpreviously can include a light source connected to a portion of thewound retractor inserted into and facing the body cavity. For example,referring to FIG. 13, around retractor 130 includes inflatable collar132 surrounding an entry opening 133 external to a patient's abdominalwall 135, a skirt 134 extending from uppermost collar 132 through anincision into a body cavity 138, and a ring 136 reinforcing thesubstantially circular opening of the end of skirt 134 distal touppermost collar 132. Encased within skirt 134 is a plurality of opticalfibers 142 extending along the length of skirt 134 toward ring 136. Theoptical fibers can also be adhered to the inner or outer walls of skirt134. The ends of fiber optic cables 142 face into the body cavity andextend around the perimeter of exit opening 140 adjacent to ring 136.The optical fibers 142 pass through skirt 134 to the outer perimeter ofentry opening 133 where they are bundled together and connected to anexternal light source 144.

[0081] Other light sources can also be used. For example the ring couldbe luminescent and the skirt pocket transparent. In particular, the ringcould be electroluminescent, so that when a current or a voltage sapplied, the ring emits light. Wire used to pass current or voltage intothe ring could be encased in the skirt as was described above for fiberoptic cables. In another embodiment, the ring material is phosphorescentand is “charged-up” by it exposing it to light, e.g., ultraviolet light,prior to use. In a further embodiment, the ring could enclosechemiluminescent material. In this case, a seal within the ring isruptured immediately prior to use, thereby mixing a plurality, ofmaterials that react with one another and emit light from the ring.

Materials and Manufacture

[0082] In the above embodiments, a gas-tight, flexible, and partiallyelastic material, such as a plastic or a rubber, is used for the skirt,collars, and the inner and outer sleeves. For example, polyethylene,polypropylene, urethane, natural rubber, or latex can be used. Thematerial for the ring provides stiffness to the lower end of the skirt.In particular, the ring should be stiff enough that it will not passthrough the incision when it is initially parallel to the inner wall ofa patient's skin and a force is drawing it tight against the inner wall.The ring can be made of, e.g., metals, polyvinyl chloride (PVC), hardrubber, and foam. Alternatively, the hem-shaped pocket could begas-tight and the ring pneumatic, with the pocket being filled with agas, liquid, or gel. During use, the pocket is filled prior to theinsertion of the exit opening into the body cavity. Methods of moldingor heating-sealing together flexible plastic materials into prescribedmedically-approved objects are well known in the art and can be carriedout by commercial entities (e.g., Dielectrics Industries, Chicopee,Mass.).

Other Embodiments

[0083] It is to be understood that while the invention has beendescribed in conjunction with the detailed description thereof, that theforegoing description is intended to illustrate and not limit the scopeof the invention, which is defined by the scope of the appended claims.For example, the surgical access port can also be used and adapted forinsertion of a surgical tool rather than, or in addition to, a surgeon'shand. Moreover, the sealing sleeve can be provided with a plurality ofaccess openings to simultaneously accommodate a plurality of handsand/or instruments that are be inserted into the body cavity. Also, therings, collars and entry and exit openings, are not limited tosubstantially circular shapes, instead they could, for example, have anelliptical shape to better accommodate the inserted object and providethe desired retraction of the incision. Furthermore, the length of thesealed side portions in the sealing sleeve can also be optimized to moreeffectively seal the inserted object.

[0084] The retractor and sealing sleeve are not limited to surgicalapplications. They can be used in any application in which the edges ofan incision into a surface is retracted into an opening, and whereappropriate, a seal is used to prevent the escape of gases through theopening.

[0085] Other aspects, advantages, and modifications are within the scopeof the following claims.

What is claimed is:
 1. A device for retracting edges of an incision in asurface to form an opening, the device comprising: a flexible, tubularskirt having an upper end, a lower end, and a channel therebetween; aring connected to the lower end of the skirt for maintaining the lowerend in an open configuration and defining an exit opening to thechannel, wherein the ring is designed to fit through the incision andremain under the surface when it is oriented parallel to surface; and aninflatable collar connected to the skirt and surrounding the upper end,wherein the collar, when inflated, maintains the upper end in an openconfiguration and defines an entry opening to the channel; whereinduring use the ring is inserted through the incision and the collar isinflated while remaining outside of the incision, thereby drawing theskirt against the edges of the incision and retracting the edges of theincision to form the opening.
 2. The device of claim 1, wherein thecollar when fully inflated has an inner aperture having a diametergreater than the length of the incision.
 3. The device of claim 1,further comprising a light source connected to the lower end of theskirt.
 4. The device of claim 3, wherein the light source is a fiberoptic cable.
 5. The device of claim 1, wherein the skirt includes ahem-shaped pocket that encloses the ring.
 6. The device of claim 1,wherein the ring is formed by filling a pocket with at least one of agas and a liquid.
 7. The device of claim 1, wherein the ring has asubstantially elliptical shape.
 8. The device of claim 1, furthercomprising a second ring adjacent to an outer perimeter of theinflatable collar for reinforcing the entry opening.
 9. The device ofclaim 8, further comprising a detachable cap for sealing the entryopening, wherein the detachable cap is adapted to be received by thesecond ring.
 10. The device of claim 1, further comprising an inflatablecuff connected to an inner wall of the skirt and surrounding the entryopening for sealing around a surgeon's arm inserted into the channel.11. The device of claim 10, further comprising a detachable plugcovering the entry opening, wherein the detachable plug is adapted to bereceived by the inflatable cuff.
 12. A surgical access port comprising:the device of claim 1; and a flexible sleeve connected to at least oneof the inflatable collar and the skirt, extending the channel from theexit opening of the skirt to an open end of the flexible sleeve distalto the skirt.
 13. The access port of claim 12, wherein the flexiblesleeve can be removed and reattached to the device of claim
 1. 14. Theaccess port of claim 12, wherein the flexible sleeve includes an innersleeve and an outer sleeve forming a chamber therebetween, and an interport for inflating the chamber, whereby inflating the chamber compressestogether a central portion of the inner sleeve, thereby sealing thechannel.
 15. The access port of claim 14, further comprising a pair ofdrawstrings attached to opposite sides of the central portion of theinner sleeve and pulling the sides in opposite directions toward theouter sleeve, thereby collapsing the central portion of the inner sleeveinto two flattened portions contacting each other to form a seal. 16.The access port of claim 14, wherein the central portion of the innersleeve includes two sealed regions opposite one another in whichimmediately adjacent portions of the inner sleeve are welded together,thereby dividing the central portion into two substantially flattenedportions extending along the length of the channel adjacent to oneanother.
 17. The access port of claim 12, further comprising a flapvalve that connects to the open end of the flexible sleeve and extendsinto the channel, wherein the flap valve seals the channel when there isa positive pressure differential between the channel and thesurroundings.
 18. The access port of claim 17, further comprising a pairof drawstrings attached to opposite ends of the flap valve and pullingthe ends in opposite directions to enhance the sealing ability of theflap valve.
 19. The access port of claim 12, further comprising a lightsource connected to the skirt in the vicinity of the exit opening. 20.The access port of claim 12, wherein the flexible sleeve comprises aniris valve.
 21. The access port of claim 12, further comprising aninflatable cuff attached to an inner surface of the sleeve for sealingaround a surgeon's arm.
 22. The access port of claim 21, wherein theinflatable cuff is surrounded by a backing of a substantiallynon-expandable material.
 23. The access port of claim 22, furthercomprising a second ring connected to the sleeve and surrounding theopen end of the sleeve.
 24. The device of claim 23, further comprising adetachable cap for sealing the open end of the sleeve, wherein thedetachable cap is adapted to be received by the second ring.
 25. Theaccess port of claim 12, further comprising: a sealing collar attachedto the sleeve and surrounding the open end, said sealing collar having agroove along its inner perimeter; and a glove comprising a flange at theopen end of the glove that mates with the groove and seals the channelwhen inserted into the groove.
 26. The access port of claim 12, furthercomprising: a sealing collar attached to the sleeve and surrounding theopen end, said sealing collar including an inwardly expanding inflatablebladder; and a glove having an enlarged cuff, wherein when the glove isinserted into the sleeve, the enlarged cuff mates with the inflatedbladder and seals the opening.
 27. The access port of claim 12, furthercomprising: a sealing collar attached to the sleeve and surrounding theopen end, said sealing collar having a groove along its inner perimeter;a bracelet having a fixed diameter that mates with the groove; and aglove, wherein during use the bracelet is worn by a surgeon underneaththe glove and is mated to the sealing collar, a portion of the glovebeing held within the groove by the bracelet, thereby sealing thechannel.
 28. A surgical access port, for use with a surgical glove,comprising: a device for retracting the edges of a surgical incision toform an opening into a patient's body cavity; a sealing sleeve attachedto the device external to the body cavity, wherein the sealing sleevecomprises, a flexible sleeve providing a channel from its open enddistal to the retracting device through to the opening, and a sealingcollar attached to the sleeve and surrounding the open end; and asemi-rigid bracelet having a fixed diameter that mates with the sealingcollar, wherein during use the bracelet is worn by a surgeon underneaththe surgical glove and is mated to the sealing collar, thereby fasteninga portion of the glove to the sealing collar and sealing the channel.29. The access port of claim 28, further comprising the glove.
 30. Amethod of using the surgical access port or claim 28, comprising thesteps of: placing the bracelet around an arm of the surgeon; placing theglove over a hand of the surgeon so that the glove extends over thebracelet; inserting the gloved hand into the access port; and attachingthe portion of the inserted glove to the access port by mating thebracelet with the sealing collar of the access port.
 31. A surgicalaccess port comprising: a device for retracting the edges of a surgicalincision to form an opening into a patient's body cavity; and a sealingsleeve attached to the device external to the body cavity, wherein thesealing sleeve comprises: a flexible sleeve providing a channel from itsopen end distal to the retracting device through to the opening; anddrawstrings connected to the flexible sleeve for sealing the channel.32. The access port of claim 31, wherein the sealing sleeve furthercomprises an outer sleeve surrounding the flexible sleeve and forming achamber therebetween, and an inlet port for inflating the chamber,whereby inflating the chamber compresses together a central portion ofthe flexible sleeve, thereby sealing the channel, and wherein thedrawstrings attach to opposite sides of the central portion of theflexible sleeve.
 33. The access port of claim 31, further comprising aflap valve that connects to the open end of the flexible sleeve andextends into the channel, wherein the flap valve seals the channel whenthere is a positive pressure differential between the channel and thesurroundings, and wherein the drawstrings attach to opposite ends of theflap valve to enhance the sealing ability of the flap valve.